Freedom of Information request on Companies permitted to import Cannabis Based Products for Medicinal Use (CBPMs)/Licensed Wholesalers of CBPMs (FOI 21-040)
Published 24 March 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-8-february-2021/freedom-of-information-request-on-companies-permitted-to-import-cannabis-based-products-for-medicinal-use-cbpmslicensed-wholesalers-of-cbpms-foi-2
Thank you for your communication to the MHRA in relation to a Freedom of Information request for the details of the full a list with companies in the UK which are allowed to import medical cannabis/ list of licensed wholesaler of medical cannabis in the UK.
For ease of reading unlicensed cannabis-based products for medicinal use in humans are referred to hereafter as unlicensed CBPMs. Comprehensive information on their supply in the UK can be found in the MHRA Guidance: The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/869284/Cannabis_Guidance__unlicensed_CBPMs__updated_2020.pdf
CBPMs are considered medicines in the UK and as such, their supply as unlicensed medicines is regulated by Regulation 167 of the Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product under certain circumstances.
An unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient that cannot be met by a licensed available medicinal product. An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient. Responsibility for deciding whether an individual patient has “special needs” which a licensed product cannot meet should be a matter for the prescriber. The requirement for a “special need” relates to the special clinical needs of the individual patient. It does not include reasons of cost, convenience or operational needs. A licensed medicinal product obtainable from normal distribution channels in a reasonable time should be considered available for use. If a licensed product becomes unavailable, it may be necessary for an unlicensed equivalent to be supplied.
The importer of an unlicensed medicinal product (a “special”) into the UK must hold:
(a) a Wholesale Dealer’s Licence (WDA (H)) if the product is to be imported from an EEA member state i.e. the EU plus Norway, Iceland and Liechtenstein, or
(b) a Manufacturer’s “Specials” Licence (MSL) if the product is to be imported from a third country i.e. a non-EEA country, for example the USA, Canada or Australia.
The list of WDA holders can be found here: https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites
The list of MSL holders can be found here: https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites
Prior to the importation taking place the importer must notify the MHRA of their intent to import the medicine and provide a set of supportive documentation to allow for our assessment of the request. The MHRA may decide to object to the importation of the unlicensed medicine if significant safety risks are identified that may potentially outweigh the benefits for the patients. If the MHRA does not object to the importation, a letter will be issued to the importer stating the conditions under which we do not object that a certain unlicensed medicine is imported.
Each import request is assessed on a case by case basis taking into account not only the product to be imported but also the special needs identified by the prescriber.
Any entity suitably licensed to import unlicensed medicines into the UK could, from an MHRA perspective, request to import unlicensed CBPMs. CBPMs are considered controlled substances and as such fall under the licensing remit of the Home Office as well. The information provided above only covers the MHRA perspective. You are advised to contact the Home Office (HO) to establish which HO requirements apply to these substances.
If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.gov.uk
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at;
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
IE&S FOI Team
MHRA
Inspection, Enforcement and Standards